(26 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional X-ray system components and image processing, without mentioning any AI/ML capabilities.
No
The device is described as a diagnostic X-Ray system used for generating diagnostic images, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "DigiX FDX uses... digital detector for generating diagnostic images," and the "Device Description" section states, "The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body."
No
The device description explicitly lists multiple hardware components (X-Ray tube suspension, Bucky stand, table, generator, tube, beam limiting device, image receptor) and describes it as a "diagnostic X-Ray system," which is inherently a hardware-based device. While it includes software, it is not solely software.
Based on the provided information, the DigiX FDX radiographic system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The DigiX FDX system is a radiographic system that uses X-rays to create images of the inside of the human body in vivo (within the body). It directly interacts with the patient to generate diagnostic images.
The description clearly states its use for radiographic exposure of the whole body and generating diagnostic images by converting X-Ray into electronic signals. This is the function of an imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications.
Exposure may be taken with the Patient's sitting, standing, or in the prone/supine position.
The DigiX FDX System is not meant for mammography.
The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
Product codes (comma separated list FDA assigned to the subject device)
KPR
Device Description
The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaging.
The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor.
The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Skull, chest, abdomen, and extremities, whole body
Indicated Patient Age Range
pediatric, adult and bariatric patients.
Intended User / Care Setting
hospitals, clinics and medical practices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing. Risk Analysis was performed on the entire system.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Allengers certify conformance to Voluntary Standards covering Electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.
Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted and results included in the submission. All functions met the design requirements and the image performance criteria satisfactorily.
Non-clinical verification test results demonstrate that the Digital Radiographic system complies with the aforementional and FDA recognized consensus standards and FDA guidance documents. Also No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed device. Hence, clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system. Bench testing was performed to assess the device safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
October 26, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Allengers Medical Systems Limited % Sanjeev Marjara Director Technical FDA Hall Unit-2, Bhankarpur, Mubarakpur Road Derabassi, Distt. Mohali, Punjab 140507 INDIA
Re: K223060
Trade/Device Name: DigiX FDX Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 20, 2022 Received: September 30, 2022
Dear Sanjeev Marjara:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name DigiX FDX
Indications for Use (Describe)
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications.
Exposure may be taken with the Patient's sitting, standing, or in the prone/supine position.
The DigiX FDX System is not meant for mammography.
The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Contact Person and Address
| Company Name: | Allengers Medical Systems Limited |
|---|---|
| Company Address: | FDA Hall, Unit-2, Bhankarpur, Mubarakpur Road, Derabassi, |
| Distt Mohali-140507, India | |
| Telephone No: | +91 1762-282600 |
| +919872980168 | |
| rnd@allengers.net | |
| Contact Person: | Sanjeev K. Marjara |
| Date Prepared: | 20.09.2022 |
2. Proposed Device:
| Device (trade) name: | DigiX FDX |
|---|---|
| Common/usual Name: | Digital X-Ray imaging system |
| Classification Name : | Stationary X-Ray system |
| Classification Panel: | Radiology |
| Regulation Number : | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| 510(K) Submission: | Special |
3. Predicate Device:
| Device (trade) name: | DigiX FDX |
|---|---|
| Common/usual Name: | Digital X-Ray imaging system |
| Classification Name: | Stationary X-Ray system |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| 510(K) Number: | K192541 |
| Clearance Date: | October 16, 2019 |
4. Reference devices:
| Device (trade) name: | Ysio |
|---|---|
| Common/usual Name: | Digital X-Ray imaging system |
| Classification Name: | Stationary X-Ray system |
| Classification Panel: | Radiology |
| Regulation Number : | 21 CFR 892.1680 |
| Device Class : | Class II |
| Product Code: | KPR |
| 510(K) Number : | K081722 |
| Clearance Date : | August 25, 2008 |
4
Allengers Medical Systems Ltd. Supplies Solid State X-Ray Image Detectors that have been previously cleared by FDA or tested and evaluated per guidance for submission of 510(K) for solid state X-Ray imaging devices. Table 1 provides the list of solid state detectors used with device.
| Solid State X-Ray Image Detectors | 510(K) Numbers |
|---|---|
| Fixed | |
| Varex PaxScan 4343R v3- Fixed | K172951 |
| Varex Paxscan 4343DXV - Fixed | K220311 |
| Varex Paxscan 4343RC - Fixed | K172951 |
| IRAY VENU 1717X – Fixed | K221714 |
| *IRAY Mercu 1717V3 - Fixed | -- |
| Allengers FP 4343R- Fixed | -- |
| *Allengers FP 4343RF- Fixed | -- |
| Varex (Perkin Elmer ) XRPAD 4343F- Fixed | K142698 |
| Wired/ Wireless | |
| InnoCare Yushan V17Ge (Wired) | K201528 |
| InnoCare Yushan V17Ce (Wired) | K220510 |
| Allengers G4343RG (Wired) | -- |
| Allengers G4343RC (Wired) | -- |
| InnoCare Yushan F14C (Wired/Wireless) | K210988 |
| InnoCare Yushan F14G (Wired/Wireless) | K210988 |
| InnoCare Yushan V14C (Wired/Wireless) | K201528 |
| InnoCare Yushan V14G (Wired/Wireless) | K201528 |
| InnoCare Yushan V17C (Wired/Wireless) | K201528 |
| InnoCare Yushan V17G (Wired/Wireless) | K201528 |
| Allengers G4336RWC (Wired/Wireless) | -- |
| Allengers G4336RWG (Wired/Wireless) | -- |
| Allengers G4343RWC (Wired/Wireless) | -- |
| Allengers G4343RWG (Wired/Wireless) | -- |
| Allengers T4336RWC (Wired/Wireless) | -- |
| Allengers T4336RWG (Wired/Wireless) | -- |
| Varex (Perkin Elmer) XRPAD 4336 – Wireless | K140551 |
| Varex PaxScan 4336W v4 + - Wireless | K192541 |
| Varex PaxScan 4343W – Wireless | K211423 |
| Varex Lumen 2530W – Wireless | -- |
| Varex Lumen 4336W – Wireless | -- |
| Varex Lumen 4343W – Wireless | -- |
| Thales Pixium 3543 DR-CS (Wireless) | K182517 |
| IRAY MARS 1417V (Wireless) | K192541 |
| IRAY MARS 1417X (Wireless) | K210316 |
| IRAY MARS 1717V (Wireless) | K201043 |
| *IRAY MARS 1717Vn (Wireless) | K201043 |
| IRAY MARS 1717X (Wireless) | K210314 |
| IRAY LUNA 1012X (Wireless) | K221345 |
| Allengers FP 4336RW (Wireless) | -- |
| Allengers FP 4343RW (Wireless) | -- |
| Allengers FP 4336RW-HR (Wireless) | -- |
| Allengers FP 4343RW-HR (Wireless) | -- |
| *Allengers FP 4343RW-DE (Wireless) | -- |
| Allengers FP 2430RW-FLX (Wireless) | -- |
Table 1 List of Solid State X-Ray Image Detectors
5
Note: The Solid State X-Ray Image Detectors (Digital detectors) marked with "* can be used with Dual Energy Subtraction feature.
5. Device description:
The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaging.
The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor.
The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.
The following in Table 2 are the specific components for various configurations of the system. A complete system will consist of a selection of one of the devices in each category.
| Component | Manufacture | Model |
|---|---|---|
| Ceiling Mounted X-Ray Tube Suspension | Allengers | CSA FDX |
| Vertical Bucky Stand | Allengers | VBS ADV |
| Vertical Bucky Stand | Allengers | VBS M XL |
| Patient Table - Fixed | Allengers | Floatex ADV |
| Patient Table - Fixed | Allengers | Floatex |
| Patient Table - Fixed | Allengers | Floatex XL |
| Patient Table - Mobile | Allengers | MobiT 6C |
| Patient Table - Mobile | Allengers | MobiT 4C |
| Patient Table - Mobile | Allengers | MobiT C |
| X-Ray Generator | Allengers | XGEN-80R |
| X-Ray Generator | Allengers | XGEN-65R |
| X-Ray Tube | Varex | A192 |
| X-Ray Tube | Varex | A292 |
| X-Ray Tube | Varex | G292 |
| X-Ray Tube | Varex | G1092 |
| X-Ray Tube | Varex | RAD14 |
| Beam Limiting Device | Ralco | R225 ACS |
| Solid State X-Ray Image Detector - Fixed | Varex | PaxScan 4343R v3 |
| Solid State X-Ray Image Detector - Fixed | Varex | Paxscan 4343DXV |
| Solid State X-Ray Image Detector – Fixed | Varex | Paxscan 4343RC |
| Solid State X-Ray Image Detector – Fixed | IRAY | VENU 1717X |
| Solid State X-Ray Image Detector – Fixed | IRAY | Mercu 1717V3 |
| Solid State X-Ray Image Detector – Fixed | Allengers | FP 4343R |
| Solid State X-Ray Image Detector – Fixed | Allengers | FP 4343RF |
| Solid State X-Ray Image Detector -Wired | Varex (Perkin Elmer) | XRPAD 4343F |
| Solid State X-Ray Image Detector – Wired | InnoCare | Yushan V17Ge |
| Solid State X-Ray Image Detector – Wired | InnoCare | Yushan V17Ce |
| Solid State X-Ray Image Detector – Wired | Allengers | G4343RG |
| Solid State X-Ray Image Detector – Wired | Allengers | G4343RC |
| Solid State X-Ray Image Detector – WiFi | Varex (Perkin Elmer) | XRPAD 4336 |
| Solid State X-Ray Image Detector – WiFi | Varex | PaxScan 4336W V4 + |
| Solid State X-Ray Image Detector – WiFi | Varex | PaxScan 4343W |
| Solid State X-Ray Image Detector – WiFi | Varex | Lumen 2530W |
| Solid State X-Ray Image Detector – WiFi | Varex | Lumen 4336W |
| Solid State X-Ray Image Detector – WiFi | Varex | Lumen 4343W |
| Solid State X-Ray Image Detector – WiFi | Thales | Pixium 3543DR-CS |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V14C |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V14G |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan F14C |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan F14G |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V17C |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V17G |
| Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1417V |
| Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1417X |
| Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1717V |
| Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1717Vn |
| Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1717X |
| Solid State X-Ray Image Detector – WiFi | IRAY | LUNA 1012X |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 4336RW |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 4336RW-HR |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 4343RW |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 4343RW-HR |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 4343RW-DE |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 2430RW-FLX |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4336RWC |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4336RWG |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4343RWC |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4343RWG |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | T4336RWC |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | T4336RWG |
| Image processing Software | e-Com | DROC |
| Image Processing Software | Allengers | Synergy DR FDX |
Table 2 Combination Details
6
7
6. Indications for Use:
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications.
Exposure may be taken with the Patient's sitting, standing, or in the prone/supine position.
The DigiX FDX System is not meant for mammography.
The DigiX FDX uses an integrated or portable or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
7. Technological Characteristics Comparison to Predicate & Reference Devices:
The Subject device DigiX FDX design is based on the Allenger's DigiX FDX (K192541) including the system control, Indication for use and mechanical design.
The modifications do not affect the intended use of the device the subject device and predicate device are based on the following same fundamental scientific technologies elements:
- . Energy emission to the patient - X-Ray
- Power requirement, Environmental requirement ●
- Mechanism to generate X-Ray .
- Mechanism to acquire, process and store image data ●
- Use of the hardware components ●
- Use of software processing ●
This 510(k) submission describes some modifications to the previously cleared predicate devices the DigiX FDX (K192541). The changes to the predicate DigiX FDX (K192541) include:
System Software Synergy DR FDX
- Graphical user interface (GUI): GUI of system software updated in order to ● improve the look and feel of user interface for better visibility & faster workflow.
- Updated to support all hardware modifications. Verification and Validation testing . concluded no impact on safety and effectiveness.
Component Change
- 25x30cm Wireless Detectors are added (Listed below), ●
- Lumen 2530W manufactured by Varex Imaging ●
- Luna 1012X manufactured by IRAY technology ●
- FP 2430RW-FLX manufactured by Allengers
8
- 43x36cm Wired/Wireless Detectors are added (Listed below), ●
- Lumen 4336W manufactured by Varex Imaging ●
- MARS 1417X manufactured by IRAY technology. .
- Yushan V14C manufactured by InnoCare Optoelectronics. ●
- Yushan V14G manufactured by InnoCare Optoelectronics. ●
- Yushan F14C manufactured by InnoCare Optoelectronics. ●
- Yushan F14G manufactured by InnoCare Optoelectronics. ●
- FP 4336RW manufactured by Allengers
- FP 4336RW-HR manufactured by Allengers
- T4336RWC manufactured by Allengers ●
- T4336RWG manufactured by Allengers ●
- G4336RWC manufactured by Allengers ●
- G4336RWG manufactured by Allengers ●
- 43x43cm Wired/Wireless Detectors are added (Listed below), ●
- Paxscan 4343W manufactured by Varex imaging ●
- Lumen 4343W manufactured by Varex Imaging
- MARS 1717V manufactured by IRAY technology. ●
- MARS 1717Vn manufactured by IRAY technology. ●
- MARS 1717X manufactured by IRAY technology.
- Yushan V17C manufactured by InnoCare Optoelectronics. ●
- Yushan V17G manufactured by InnoCare Optoelectronics. ●
- Yushan V17Ge manufactured by InnoCare Optoelectronics.
- Yushan V17Ce manufactured by InnoCare Optoelectronics. ●
- FP 4343RW manufactured by Allengers ●
- . FP 4343RW-HR manufactured by Allengers
- FP 4343W-DE manufactured by Allengers ●
- G4343RWC manufactured by Allengers ●
- G4343RWG manufactured by Allengers ●
- G4343RG manufactured by Allengers .
- . G4343RC manufactured by Allengers
- 43x43cm Fixed Detectors are added (Listed below), .
- Paxscan 4343RC manufactured by Varex imaging ●
- Mercu 1717V3 manufactured by IRAY technology.
- . FP 4343R manufactured by Allengers
- FP 4343RF manufactured by Allengers ●
8. Software Feature
Synergy DR FDX imaging software manufactured by Allengers Medical systems Limited is a Digital Imaging System (DIS) provides useful functions to manage X-Ray images obtained from digital radiography system.
The software feature set and functions is essentially the same as the device, with the system complying with DICOM 3.0 specifications .Refer to 'Image processing and storage' in Section 13 (Page 5-0-10 to page 5-0-12) under table 4 of this document for a list of top level functions.
9
9. Substantial Equivalence:
The DigiX FDX radiographic X-Ray system is substantially equivalent to the commercially available predicate Allenger's DigiX FDX Cleared October 16, 2019 with K192541 and Ysio (K081722).
Mechanical dimensions was slightly change, however the changes doesn't impact the intended use of device. Table 3 provides primary and secondary predicate comparable information.
| Predicate Device(s) Name
and Manufacture | 510(K)
Number | Clearance Date | Comparable
Properties |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------|----------------------------------------------------|
| Predicate Device
DigiX FDX
Product Code: KPR
Address: Allengers Medical
Systems Ltd. Bhankharpur,
Mubarakpur
Road, Derabassi, Distt
Mohali-140507 India | K192541 | 10/16/2019 | Technical Design Mechanical Design System Software |
| Reference Device: Ysio
Product Code: KPR
Address: Siemens Medical
Solutions USA, Inc,
51 valley stream, Parkway E-
50, Malvern PA, 19335-1406 | K081722 | 8/25/2008 | Technical Design Mechanical Design System Software |
Table 3 Predicate Device Comparable Properties
10
| Feature | DigiX FDX
(Subject Device) | DigiX FDX
(Predicate Device) | Siemens Ysio
(Reference Device) | Justification for
differences | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------|
| 1. 510(k) | This submission | K192541 | K081722 | | | |
| 2. Product Code | | | | | | |
| Product
Classification
Code | KPR | KPR | KPR | Same | | |
| 3. Product Classification | | | | | | |
| Classification | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 | Same | | |
| 4. Indication for Use | The DigiX FDX radiographic
systems are used in
hospitals, clinics and
medical practices. DigiX
FDX enables radiographic
exposure of the whole body
including: Skull, chest,
abdomen, and extremities
and may be used on
pediatric, adult and bariatric
patients. It can also be used
for intravenous, small
interventions (like biopsy,
punctures, etc.) and
emergency (trauma critical
ill) applications.
Exposure may be taken with
the Patient's sitting,
standing, or in the
prone/supine position.
The DigiX FDX System is
not meant for
mammography.
The DigiX FDX uses an
integrated or portable or
fixed or Wi-Fi digital detector
for generating diagnostic
images by converting X-Ray
into electronics signals.
DigiX FDX is also designed
to be used with conventional
film/screen or Computed
Radiography (CR)
Cassettes. | The DigiX FDX
radiographic systems are
used in hospitals, clinics
and medical practices.
DigiX FDX enables
radiographic exposure of
the whole body including:
Skull, chest, abdomen,
and extremities and may
be used on pediatric,
adult and bariatric
patients. It can also be
used for intravenous,
small interventions (like
biopsy, punctures, etc.)
and emergency (trauma
critical ill) applications.
Exposure may be taken
with the Patient's sitting,
standing, or in the
prone/supine position.
The DigiX FDX System is
not meant for
mammography.
The DigiX FDX uses an
integrated or portable or
fixed or Wi-Fi digital
detector for generating
diagnostic images by
converting X-Ray into
electronics signals. DigiX
FDX is also designed to
be used with
conventional film/screen
or Computed
Radiography (CR)
Cassettes. | The Ysio (New RAD
Family) systems are
the radiographic
systems used in
hospitals, clinics, and
medical practices.
Ysio enables
radiographic and
tomographic
exposures of the
whole body including:
skull, chest,
abdomen, and
extremities and may
be used on pediatric,
adult and bariatric
patients. It can also
be used for
intravenous, small
interventions (like
biopsy, punctures,
etc.) and emergency
(trauma, critical ill)
applications.
Exposures may be
taken with the patient
sitting, standing, or in
the prone position.
The Ysio system is
not meant for
mammography. The
Ysio uses an
integrated or portable
digital detector for
generating diagnostic
images by converting
X-Rays into electronic
signals. Ysio is also
designed to be used
with conventional
film/screen or
Computed
Radiography (CR)
Cassettes | Essentially the
same
Note: There are
no
differences
between
the subject device
and the predicate
with respect to
indication and
intended use. | | |
| Feature | DigiX FDX
(Subject Device) | DigiX FDX
(Predicate Device) | Siemens Ysio
(Reference Device) | Justification for
differences | | |
| 5. X-Ray Generator | | | | | | |
| Power | XGEN-80R : 80KW | XGEN-80R : 80KW | 80KW Standard | | | |
| Rating (KW) | XGEN-65R : 65KW | XGEN-65R : 65KW | 65KW Optional | Same | | |
| kV minimum
(65/80) | 40/40 kV | 40/40 kV | 40/40 kV | Same | | |
| kV maximum
(65/80) | 150/150 kV | 150/150 kV | 150/150 kV | Same | | |
| mA
maximum @
100kV
(65/80) | 650/800 mA | 650/800 mA | 650/800 mA | Same | | |
| mAs Range
(65/80) | 800/1000mAs | 800/1000mAs | NS | Same as predicate
device | | |
| APR
programming | Yes | Yes | Yes | Same | | |
| IR Remote | Yes | Yes | NA | Same as
predicate device | | |
| 6. X-Ray Tube | | | | | | |
| Make /
Model | Varex Imaging/ G1092
Varex Imaging/ G292
Varex Imaging/ A292
Varex Imaging/ A192
Varex Imaging/RAD14 | Varex Imaging/G1092
Varex Imaging/ G292
Varex Imaging/ A292
Varex Imaging/ A192
Varex Imaging/RAD14 | Siemens OPTITOP
Siemens OPTILIX | Same as
Predicate Device | | |
| | 7. Solid State X-Ray Image Detectors | | | | | |
| | Varex's PaxScan 4343R v3
Varex's PaxScan 4343DXV
Varex's, Paxscan 4343RC
Iray, VENU 1717X
Iray, Mercu 1717V3
Allengers, FP 4343R
Allengers, FP 4343RF
InnoCare's, Yushan V17Ce
InnoCare's,Yushan V17Ge
Allengers, G4343RC
Allengers, G4343RG | Varex's PaxScan 4343R
v3
Varex's, Paxscan
4343CB
Iray, VENU 1717X | Trixell Pixium 4600 | Additional Solid
state X-Ray
Image detectors
from the predicate
can be used with
the system. The
system has been
tested and there
is "No negative
impact on safety
or efficacy" .
There is no new
potential or
increased safety
risks concerning
were raised
because of this
difference. | | |
| Make /
Model | Varex's, XRPAD 4343 F
Varex's, XRPAD 4336
Varex's PaxScan 4336Wv4+
Varex's PaxScan 4343W
Varex's Lumen 2530W
Varex's Lumen 4336W
Varex's Lumen 4343W
Thales Pixium 3543 DR-CS
InnoCare's,Yushan F14C
InnoCare's,Yushan F14G
InnoCare's,Yushan V14C
InnoCare's,Yushan V14G
InnoCare's,Yushan V17C
InnoCare's,Yushan V17G
Iray, MARS 1417V
Iray, MARS 1417X
Iray's MARS 1717V
Iray, MARS 1717Vn | Varex's, XRPAD 4343 F
Varex's, XRPAD 4336
Varex's PaxScan 4336W
v4 +
Varex's PaxScan 4336W
Varex's PaxScan 4336W
V4
Thales Pixium 3543 DR-
CS
Iray, MARS 1417V | Trixell Pixium 4600
Thales Pixium 3543 | | | |
| Feature | DigiX FDX
(Subject Device) | DigiX FDX
(Predicate Device) | Siemens Ysio
(Reference Device) | Justification for
differences | | |
| | Iray's MARS 1717X
Iray's Luna 1012X
Allengers, FP 4336RW
Allengers, FP 4343RW
Allengers, FP 4336RW-HR
Allengers, FP 4343RW-HR
Allengers, FP 4343RW-DE
Allengers, FP 2430RW-FLX
Allengers, G4336RWC
Allengers, G4336RWG
Allengers, G4343RWC
Allengers, G4343RWG
Allengers, T4336RWC
Allengers, T4336RWG | | | | | |
| 8. Ceiling Mounted X-Ray Tube Suspension | | | | | | |
| Model | CSA FDX | CSA FDX | Ysio | Same as
Predicate device | | |
| 9. Vertical Bucky Stand | | | | | | |
| Model | VBS ADV
VBS M XL | VBS ADV
VBS M XL | BWS with Max static
BWS wi-D | Same as
Predicate device | | |
| 10. Patient Table | | | | | | |
| Model | Floatex XL
Floatex ADV
Floatex
MobiT 6C
MobiT 4C
Mobit C | Floatex XL
Floatex ADV
Floatex
MobiT 6C
MobiT 4C
Mobit C | Bucky Table | Same as
Predicate device | | |
| 11. Beam Limiting Device | | | | | | |
| Construction | Multi-leaf | Multi-leaf | Multi-leaf | Same | | |
| CFR 21
1020.31 | Compliant | Compliant | Compliant | Same | | |
| Automatic | Yes | Yes | Yes | Same | | |
| 12. Viewing Monitors | | | | | | |
| Monitor
(minimum
Size) | 19 inch or more (Touch and
Non Touch) | 19 inch or more (Touch
and Non Touch) | 19 inch Monitor | Same as
Predicate device | | |
| 13. Image Processing and storage | | | | | | |
| Model | Synergy DR
FDX | DROC | DelWorks DR
System | -- | | |
| FDA Cleared | -- | K130883 | Yes, K140825 | -- | | |
| Operating
System | Microsoft
Windows7/
Microsoft
Window 10 | Microsoft
Windows7/
Microsoft
Window 10 | Microsoft Windows7 | Same as
Predicate device | | |
| Network | Ethernet/ Wifi | Ethernet/
Wifi | Ethernet/ Wifi | Same | | |
| User | Mouse,
Keyboard, | Mouse,
Keyboard | Mouse, Keyboard, | Same | | |
| Interaction | Touch | Touch | Touch Monitor | Same | | |
| Feature | DigiX FDX
(Subject Device) | | DigiX FDX
(Predicate Device) | | Siemens Ysio
(Reference Device) | Justification for
differences |
| /input | Monitor, | Monitor, | Monitor, | Monitor, | Available | |
| Multi-user | Available | Available | Available | Available | Available | Same |
| Import/Expor
t images | Yes | Yes | Yes | Yes | Yes | Same |
| Acquisition
device | Computed
Radiography
Digital X-Ray
Detector | Computed
Radiograph
y Digital X-
Ray
Detector | Computed
Radiogra
phy
Digital X-
Ray
Detector | Computed
Radiography
Digital X-Ray
Detector | Computed
Radiography Digital
X-Ray Detector | Same |
| Image
Interference
s | Detector
dependent | Detector
dependent | Detector
dependent | Detector
dependent | Detector dependent | Same |
| Image
Organization | Yes
Patient
ID / Name
/Age / DOB/
Study
instance UID | Yes
Patient
ID / Name
/Age /
DOB/ Study
instance
UID | Yes
Patient
ID /
Name
/Age /
DOB/
Study
instance
UID | Yes
Patient
ID / Name
/Age / DOB/
Study
instance UID | Yes
Patient ID / Name
/Age / DOB/ Study
instance UID | Same |
| Image
Search
available | Yes | Yes | Yes | Yes | Yes | Same |
| Image
Storage | Yes | Yes | Yes | Yes | Yes | Same |
| Database
storage | Yes | Yes | Yes | Yes | Yes | Same |
| Database
Software | MS-Access | MS-Access | MS-Access | MS-Access | MS-Access | Same |
| Image
Viewing | Yes | Yes | Yes | Yes | Yes | Same |
| Image
measureme
nt | Yes | Yes | Yes | Yes | Yes | Same |
| Image
Annotation | Yes | Yes | Yes | Yes | Yes | Same |
| Image
Operation | Yes | Yes | Yes | Yes | Yes | Same |
| Image
Stitching | Automatic | Manual | Automatic | Manual | Manual | Same as
Predicate device |
| DICOM 3.0
Compatibility | Yes | Yes | Yes | Yes | Yes | Same |
| Generator
Control | Yes | Yes | Yes | Yes | Yes | Same |
| Generator
Control
Protocols | | Generator dependent | | Generator dependent | | Same |
Table 4: Functional and specification differences
11
12
13
14
| Feature | DigiX FDX
(Subject Device) | DigiX FDX
(Predicate Device) | Siemens Ysio
(Reference Device) | Justification for
differences |
|----------------------------------|-------------------------------|---------------------------------|------------------------------------|----------------------------------|
| Raw image
Data
Processing | Yes | Yes | Yes | Same |
| Post image
data
processing | Yes | Yes | Yes | Same |
| RIS code
manager | Yes | Yes | Yes | Same |
| Dual Energy
Subtraction | Yes | No | No | Same as
Predicate device |
| 14. Power Requirement | | | | |
| Power
Requirement | 400 VAC ,(±10% ) 50/60 Hz | 400 VAC,(±10%) 50/60 Hz | 400 VAC,
(±10%)50/60 Hz | Same |
| 15. Biological Characteristics | | | | |
| Table Top
Material | Carbon Composite Material | Carbon Composite
Material | Carbon Composite
Material | Same |
10. Reason for Submission
Modification of cleared device
11. Description of Non Clinical & Clinical testing
Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing. Risk Analysis was performed on the entire system.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Allengers certify conformance to Voluntary Standards covering Electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.
Safety Information:
This system demonstrates compliance with the following 21 CFR Federal Performance Standards:
- 1020.30 Diagnostic X-Ray Systems and their major components .
- 1020.31 Radiographic equipment ●
and with the following relevant voluntary FDA Recognized Consensus Standards as listed in the table below:
| Recognition
Number | Product
Area | Title of standard | Reference
Number and
date | Standard
Development
organization |
|-----------------------|-----------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------|-----------------------------------------|
| 19-4 | General | Medical Electrical Equipment -
Part 1: General requirements for
basic safety and essential
performance | 60601-1:2012,
ed. 3.1 | IEC |
15
| 19-8 | General | Medical electrical equipment - Part
1-2: General requirements for basic
safety and essential performance –
Collateral Standard:
Electromagnetic Compatibility –
Requirements and tests | 60601-1-2
Edition 4.0
2014-02 | IEC |
|--------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----|
| 12-269 | Radiology | Medical Electrical Equipment Part
1-3: General Requirements for
Basic Safety and Essential
Performance.-Collateral Standard:
Radiation Protection in Diagnostic
X-Ray Equipment. | 60601-1-3
Edition 2.1
2013-04 | IEC |
| 12-296 | Radiology | Medical Electrical Equipment- Part
2-54: Particular Requirements for
the Basic Safety and Essential
Performance of X-Ray Equipment
for Radiography and Radioscopy | 60601-2-54,
(Edition 1.1
2015). | IEC |
| 13-79 | General | Medical device software - Software
life cycle processes | 62304 (Edition
1.1, 2015) | IEC |
| 5-89 | General | Medical Electrical Equipment Part
1-6: General Requirements for
Basic Safety and Essential
Performance- Collateral Standard:
Usability | 60601-1-6,
(Edition 3.1
2013). | IEC |
| 5-114 | General | Application of Usability Engineering
to Medical Devices | 62366-1 Edition
1.0 2015-02 | IEC |
| 5-125 | General I
(QS/RM) | Medical devices - application of
risk management to medical
devices | 14971 Third
Edition 2019-12 | ISO |
| 12-273 | Radiology | Safety of laser products - Part 1:
Equipment classification, and
requirements | 60825-1 Edition
2.0
2007-03 | IEC |
Table 4: FDA Guidance Documents
| FDA Guidance Documents and Effective Date | |
|---|---|
| 1 | Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket |
| Notification Submissions 510(k) | |
| Document issued on October 2, 2017 | |
| 2 | Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy |
| for 510(k)s | |
| Document issued on April 21, 2022. | |
| 3 | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s - |
| Guidance for Industry and FDA Staff | |
| Document issued on September 13, 2019. | |
| 4 | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: |
| Evaluating Substantial Equivalence in Premarket Notifications [510(k)] | |
| Document Issued on July 28, 2014 | |
| 5 | Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s for Solid |
| State X-ray Imaging Devices | |
| Document issued on September 1, 2016 | |
| 6 | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket |
| Submission for Software in Medical Devices | |
| Document issued on May 11, 2005 | |
| 7 | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in |
| Medical Devices | |
| Document issued on September 27, 2019 |
16
| 8 | Guidance for Industry and FDA Staff: Applying Human Factors and Usability
Engineering to Medical Devices.
Document issued February 3, 2016 |
|----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 9 | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device
Premarket Notifications.
Document issued on November 28, 2017 |
| 10 | Guidance for Industry and FDA Staff: Content of Premarket Submissions for
management of Cybersecurity in Medical devices.
Document issued on October 2, 2014 |
| 11 | Guidance for Industry and FDA Staff: Electromagnetic Compatibility (EMC) of Medical
Devices
Document issued on June 6, 2022 |
Performance Testing:
Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted and results included in the submission. All functions met the design requirements and the image performance criteria satisfactorily.
Non-clinical verification test results demonstrate that the Digital Radiographic system complies with the aforementional and FDA recognized consensus standards and FDA guidance documents. Also No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed device. Hence, clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system. Bench testing was performed to assess the device safety and effectiveness.
12. Substantial Equivalence Conclusion:
DigiX FDX, Digital Radiography System does not introduce any new indications for use, nor does the use of the systems result in any new potential hazards. The subject device is substantially equivalent to the DigiX FDX (K192541) and Ysio (K081722) . The intended use, the design principle, and the applicable standards for the subject device are identical to those of the predicate & reference device. Some characteristics, for example, their appearance, the user interfaces and the physical dimensions are different. However, the performance test and non-clinical consideration result demonstrate that these differences do not raise any new questions of safety and effectiveness. Therefore, it is the Allengers opinion that the subject device appears to be as safe and effective as the predicate & reference device.